Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function

The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects

Sponsors

Lead Sponsor: Danisco

Collaborator: University of Turku
4Pharma Ltd.

Source Danisco
Brief Summary

Effect of apple polyphenols on FMD.

Detailed Description

The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.

Overall Status Completed
Start Date 2012-08-01
Completion Date 2013-05-01
Primary Completion Date 2013-05-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Brachial flow-mediated dilation test (FMD) At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after.
Secondary Outcome
Measure Time Frame
Nitrate-mediated vasodilatation response (NMD) At the first and last visits of both periods, approximately 10 minutes after FMD.
Circulating biomarkers of vascular function Once at the first visit of both periods and once at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
BP Once at the first visit of both periods and once at the last visit of both periods. Blood pressure will be recorded twice prior to the morning dose.
Plasma epicatechin concentration At the first visit of both periods and at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
Enrollment 57
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Epicatechin

Arm Group Label: Epicatechin

Intervention Type: Dietary Supplement

Intervention Name: Microcrystalline cellulose

Arm Group Label: Microcrystalline cellulose

Eligibility

Criteria:

Inclusion Criteria: - Borderline hypertension - Otherwise healthy - Aged 40-65 years (inclusive) - Not consuming high amounts (over 20 mg daily) of flavonoids Exclusion Criteria: - BMI >32 kg/m2 - Total serum cholesterol ≥ 8 mmol/l - Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant - Coronary artery disease - Pregnancy or lactating - Alcohol abuse as evaluated by medical history - Regular smoking/using nicotine products - Diabetes mellitus - Apple allergy - Use of lipid lowering medications - Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction - Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject - High consumption of vitamin products, herbal remedies or products containing flavonoids

Gender:

All

Minimum Age:

40 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Location
Facility: University of Turku
Location Countries

Finland

Verification Date

2014-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Epicatechin

Type: Active Comparator

Description: The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods.

Label: Microcrystalline cellulose

Type: Placebo Comparator

Description: The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Supportive Care

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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